Regulatory Strategist

About the role

The Polio, Pertussis and Haemophilus influenzae type b (Hib) or PPH franchise is dedicated to safeguarding health through vaccines that protect against Polio, Pertussis, Tetanus, Hib, Diphtheria, and Hepatitis B. The RA PPH team is responsible for developing and executing strategic regulatory initiatives that maintain market leadership, support continuous product improvements, and ensure sustained compliance with evolving global regulations. The team serves as the critical interface between R&D, manufacturing, and Health Authorities to navigate regulatory requirements, manage lifecycle strategies, and drive market access for the PPH vaccine portfolio.

This position requires agility to work transversally across the PPH Franchise and the broader Vaccines Global Business Unit (GBU), with a primary focus on PPH combination vaccines across Canadian and French products, and flexibility to support other Therapeutic Areas within the GBU as needed. The scope of the licensing work will include both established product licensing and Research and Development. As a key member of the GRT and strategic partner to the GRL, the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority interactions.

Responsibilities

• Enable the GRL by providing quality regulatory input and position to internal business partners, including clinical development teams, commercial, and Global Regulatory Team for assigned projects.
• Liaise with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes.
• Contribute to the development of a harmonized regulatory voice through participation in appropriate committees and forums at the direction of the GRL.
• Contribute to the Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on governance committees.
• May represent GRT strategic position on behalf of the GRL at regulatory forums/committees at the request of the GRL.
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed.
• Identify regulatory risks and propose mitigations in collaboration with the GRL to cross-functional teams using Sanofi standardized methodologies as appropriate.
• Contribute to the development of Global Regulatory Project Strategy and ensure alignment with the core product labeling for vaccines in their remit.
• Ensure respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities.
• Lead submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet project timelines for product launch and are responsible for the development and update of the core global dossier; collaborate with regional lead where region-specific submissions are applicable.
• Lead the IND/CTA submission strategy to ensure preparation timelines meet project timelines for clinical trial initiation.
• Contribute to content and review regulated documents (such as IB, PBRER, DSUR, RMP, etc.).
• Accountable for developing Health Authority engagement and interaction plans for assigned products, including authoring briefing documents focused on strategy and scientific content, leading the team through meeting preparations, and moderating the meeting itself.
• Attend and may lead Health Authority meetings as designated.
• Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including generating submission content plans, submission tracking, and document management.
• Accountable for complete and accurate communication/interaction (including tracking) with relevant Health Authorities for the projects/products in their remit.

Qualifications

Bachelor’s degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience OR Advanced degree (PharmD, PhD, MD, or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience.

Skills

• Emerging understanding of clinical development of drugs and/or novel biologics products. Vaccines experience is a plus.
• Ability to work in electronic document management systems, e.g., Veeva Vault is a plus.
• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred.
• Proactively contribute with curiosity and openness to diverse perspectives.
• Demonstrates business acumen, leadership, influencing, and negotiation skills.
• Strong sensitivity for a multicultural/multinational environment.
• Effective communication skills, specifically strong oral and written presentation skills preferred.

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.